Endotracheal Intubation
Conditions
Brief summary
The purpose of this research is to learn about the difference in the endotracheal intubation condition (ease of using a device to view vocal cords, position of vocal cords, and patient's reaction to endotracheal tube insertion) and determining the appropriate time to perform the intubation.
Interventions
PROCEDUREEndotracheal Intubation 2 minutes after rocuronium administration
Intubation using a video laryngoscopy will be performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine)
PROCEDUREEndotracheal Intubation at TOFC=1
Intubation using a video laryngoscopy will be performed after train-of-four (TOFC) stimulation indicates neuromuscular blockade
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients willing to participate and provide an informed consent. * Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively.
Exclusion criteria
* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury. * Patients with systemic neuromuscular diseases such as myasthenia gravis. * Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents; i.e., severe renal impairment or end-stage liver disease. * Patients having surgery that would involve prepping the arm into the sterile field. * Patients receiving a rapid sequence induction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Optimal Intubating Conditions | Approximately 15 minutes after intubation | The number of subjects who had optimal intubating conditions (total composite score of 3) will be evaluated by the healthcare providers using a scale that includes 3 variables (ease of laryngoscopy, vocal cord position, and reaction to tracheal tube insertion) with 3 response options per each evaluation. The composite score (1-3) will be used, with the lowest total score of 3 correlating with optimal intubating conditions and the highest score of 9 representing the worse possible intubating conditions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intubation at TOFC=1 Subjects scheduled for an elective surgical procedure had endotracheal intubation performed when muscles were almost relaxed and monitoring showed only a single count of muscle twitch (in response to a monitor that assessed muscle relaxation)
Endotracheal Intubation at TOFC=1: Intubation using a video laryngoscopy was performed after train-of-four (TOFC) stimulation indicated neuromuscular blockade | 85 |
| Intubation 2 Minutes After Rocuronium Administration Subjects scheduled for an elective surgical procedure had endotracheal intubation performed 2 minutes after the anesthesia provider gave muscle relaxing medication
Endotracheal Intubation 2 minutes after rocuronium administration: Intubation using a video laryngoscopy was performed 2 minutes after administration of rocuronium at 0.6 mg/kg (usual current clinical routine) | 85 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 2 |
Baseline characteristics
| Characteristic | Intubation at TOFC=1 | Total | Intubation 2 Minutes After Rocuronium Administration |
|---|---|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 12.9 | 59.4 years STANDARD_DEVIATION 13.9 | 59.1 years STANDARD_DEVIATION 14.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants | 158 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 79 Participants | 157 Participants | 78 Participants |
| Region of Enrollment United States | 85 participants | 170 participants | 85 participants |
| Sex: Female, Male Female | 40 Participants | 78 Participants | 38 Participants |
| Sex: Female, Male Male | 45 Participants | 92 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 85 |
| other Total, other adverse events | 0 / 85 | 0 / 85 |
| serious Total, serious adverse events | 0 / 85 | 0 / 85 |
Outcome results
Primary
Number of Subjects With Optimal Intubating Conditions
The number of subjects who had optimal intubating conditions (total composite score of 3) will be evaluated by the healthcare providers using a scale that includes 3 variables (ease of laryngoscopy, vocal cord position, and reaction to tracheal tube insertion) with 3 response options per each evaluation. The composite score (1-3) will be used, with the lowest total score of 3 correlating with optimal intubating conditions and the highest score of 9 representing the worse possible intubating conditions.
Time frame: Approximately 15 minutes after intubation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intubation at TOFC=1 | Number of Subjects With Optimal Intubating Conditions | 61 Participants |
| Intubation 2 Minutes After Rocuronium Administration | Number of Subjects With Optimal Intubating Conditions | 47 Participants |
p-value: 0.036Wilcoxon (Mann-Whitney)